Monday, January 20, 2014

#pharmaban

Something very interesting is happening at the British Medical Journal. Last year, the editors made the wise and principled decision to stop publishing studies funded by tobacco money. In the discussion that ensued, Richard Smith, former BMJ editor, asked: “So will the editors stop publishing research funded by the pharmaceutical industry, and if not why not?” (Adding snarkily: “Knowing the heavy financial dependence of journals on the pharmaceutical industry, I shall be looking for sophistry in the explanations.”)

The arguments for a ban are very strong – unassailable, really, particularly if you favor the tobacco-studies ban.* Smith and Gøtzsche open their argument:

The BMJ and its sibling journals have stopped publishing research funded by the tobacco industry for two main reasons: the research is corrupted and the companies publish their research to advance their commercial aims, oblivious of the harm they do.1 But these arguments apply even more strongly to research funded by the drug industry, and we suggest there is a better way to communicate the results of trials that would be safer for patients.

They go on to provide concrete evidence, of which there’s an overwhelming amount, of the corrupt and harmful nature of commercial drug and device research and publication. They also offer concrete suggestions for alternative means of developing and communicating clinical trials.

Groves’ response isn’t much of anything, as it doesn’t address the information provided in Smith and Gøtzsche’s statement or make a convincing case against a ban. In fact, even without acknowledging some of their evidence she admits some facts that help the case for the ban (“Only about one in 10 newly approved drugs substantially benefits patients”; “How much can we trust the evidence base for drugs in current use? It’s hard to tell, given the woeful legacy of widespread non-registration, non-publication, and selective reporting of clinical trials”). Most significantly, she doesn’t - because she can’t - successfully contest the similarities between pharma and the tobacco industry that form the basis of the argument for extending the ban.

I should quote a couple of sentences, because I found them telling. Groves asserts that “The drug and tobacco industries, notwithstanding the inescapable fact that both are out to make money, have very different aims.” This of course isn’t so. The first part of the sentence tells the important story. Corporations in both industries are out to make money, and the drugmakers’ history of behavior and the harms they’ve caused show clearly the dominance of this orientation.**

The argument that drug companies (or agribusiness or food manufacturers or the fossil fuels industry) specialize in products related to human needs and therefore should be treated more generously than the tobacco industry, looked at from another angle, is actually quite perverse. The extensive evidence that pharma engages in the same damaging practices as corporations in all industries is reason to argue that for-profit companies should not be involved in medicine. The interest in making money is so rarely coincidental with public health needs, and so often opposed to them, that it’s plainly naïve to think that such a system is ideal or even acceptable. Our health is far too important to be entrusted to a system in which commercial motives play a role.

This issue of trust is central. It’s not that drugmakers are less trustworthy than corporations in other industries – they’re all equally untrustworthy. But people have to trust in medicine to a greater extent than they do in other realms. People don’t have the time or resources or expertise to evaluate thoroughly every piece of advice or prescription given or device used on them or their children. They have to trust to a great degree in government agencies and regulators, doctors, medical organizations, scientists, universities, patients’ advocacy groups, and, yes, medical journals to have their interests – and the interests of scientific medicine - at heart.

Currently, that trust is misplaced. I’ve been arguing for years that corporations have no place in medicine (or anywhere else, for that matter, but especially in medicine). But even those who disagree with that position can surely recognize that the fact that these corporations are making and selling drugs that are going to be prescribed to people means that others involved in medicine have not a responsibility to be more trusting but a heightened responsibility to put in place strong safeguards to protect people.

Right now, drugmakers pay billions in criminal fines for actions resulting in widespread suffering, death, and waste; meanwhile, they’re allowed not only to participate in the system but to wield enormous influence. Pharma involvement with medical publishing is clear and demonstrated,*** and it harms not only medical science and real human beings but the journals themselves. Groves asks:

[A]re we editors afraid or unable to extend the ban to pharmaceutical research because our journals receive advertising, reprint, and some sponsorship income from the drug industry (www.bmj.com/about-bmj)? No; that’s not the reason. As Fiona Godlee, the BMJ’s editor in chief, said in her response to Richard Smith’s challenge, ‘If these efforts do not soon bring about a necessary sea change in the way industry funded trials are performed, the BMJ may well decide to stop publishing them. Whether an editor would survive such a decision is a question I may have to test’.

Journals can continue to support (“encourage,” “welcome,”…) wider reforms and efforts to increase transparency, but they shouldn’t hang around waiting for those reforms to take or have effect. Like the tobacco ban, a ban on pharma-sponsored studies, which could be revised or loosened in response to any other reforms enacted in the future, is an action that journals can take right now to defend and support medicine, science, and public health. It wouldn’t only be an effective act but a display of integrity that could potentially inspire other organizations to stop talking about hypothetical reforms and to take similar concrete steps.

IMPORTANT: If you’re on Twitter (which I’m not) you can “Join the authors live…to debate the issue on 21 January, 1200-1230 GMT at #pharmaban.

* The parallel isn’t strictly necessary to the case for banning pharma-funded studies. Even if, for some reason, you rejected the ban on publishing tobacco-funded studies, you could still accept the pharma ban on the basis of the evidence in this case alone. The most consistent position, of course, is to refuse to publish research funded by for-profit corporations or their agents in any industry.

** While the tobacco industry makes harmful products, Groves argues, “[t]he drug industry makes and sells products aimed at improving health.” As a commenter points out, this “could read ‘“marketed as” improving health’, as tobacco once was” [my emphasis – SC]. It’s astounding and very suggestive that a medical journal editor could publicly state something this ingenuous. The drug industry makes and sells products aimed at making money. Groves goes on to quote Gro Harlem Brundtland from 1999: “A cigarette is the only consumer product which when used as directed kills its consumer.” “Whatever your concerns about the drug industry and the safety of drugs,” she insists, “you’d be hard pushed to make the same allegation.” But this is utterly bizarre: Smith and Gøtzsche provide clear evidence of pharma products used as directed killing large numbers of people in the very piece to which she’s responding.

*** One of Groves’ more casual remarks is symptomatic of how far the pharma-corrupted perspective has penetrated medical science. She offers some suggestions for potential reforms from Garattini and Chalmers – none of which involves the journal directly – that would need drug company cooperation. She then explains why such reforms might be agreed to: “More openness could help to transform the drug industry’s image and performance, they say, and perhaps in return governments could extend patent time.” The notion, expressed by a medical journal editor, that governments should offer corporations that have been acting like criminal organizations for decades anything – much less extended patents! – “in return” for abiding by basic standards of scientific integrity, decency, and legality reveals the depth of the problem.

1 comment:

Thanks for covering our debate. Just to clarify: the two halves of a BMJ Head to Head are written separately, without sight of each other and without comparing notes. Trish Groves, Head of Research, BMJ